Real Time Image Gating System for Proton Beam Therapy Systems

{0}------------------------------------------------ December 26, 2017 Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text. Hitachi, Ltd. Healthcare % Mr. Jonathan Kahan Regulatory Counsel Hogan Lovells US LLP 555 Thirteenth Street. NW WASHINGTON DC 20016 # Re: K171049 Trade/Device Name: Real Time Image Gating System for Proton Beam Therapy Systems Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: LHN Dated: December 1, 2017 Received: December 1, 2017 Dear Mr. Kahan: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. 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For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Michael D. O'Hara For Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ 510(k) Number (if known) #### K171049 Device Name Real Time Image Gating System for Proton Beam Therapy Systems Indications for Use (Describe) The Real Time Image Gating System for Proton Beam Therapy Systems is intended for use with compatible Hitachi proton beam therapy systems and is designed to generate gating signals to deliver a proton beam when the position of a fiducial marker, which is implanted near a tumor and tracked by use of X-ray fluoroscopy, is within a given tolerance from its planned position. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ #### 510(k) SUMMARY #### Hitachi Ltd.'s Real Time Image Gating System #### Submitter Hitachi Ltd. Healthcare Hitachi Works 3-1-1, Saiwai-cho, Hitachi-shi lbaraki, JAPAN 317-8511 Phone: +81-294-555232 Facsimile: +81-294-559946 Contact Person: Tomoyuki Seino Date Prepared: April 7, 2017 ### Name of Device: Real Time Image Gating System for Proton Beam Therapy Systems #### Common or Usual Name: System, radiation therapy, charged-particle, medical ### Classification Name: Medical charged-particle radiation therapy system (21 CFR 892.5050) ### Regulatory Class: Class II ### Product Code: LHN ### Predicate Devices K133914 MedCom GmbH's Verisuite K131965 Elekta Ltd.'s XVI R5.0 #### Reference Devices K160432 Anzai Medical's AZ-733VI {4}------------------------------------------------ ### Device Description The Real-time Image Gating System for proton beam therapy (RGS) is a gating signal generator accessory to proton beam therapy systems (PBTS) and used to track an implanted fiducial and to control the proton beam. The RGS is installed on the PBTS workstation and receives information from the PBTS imaging systems, processes the images, and sends timing signals to the PBTS irradiation controller. This RGS system recognizes the position of a fiducial marker in the human body at a regular frame rate using the X-ray imaging systems. The marker is implanted near the tumor using image guided implantation. Using two diagnostic X-ray sources and two X-ray FPDs configured around the treatment isocenter, the imaging data are combined to obtain precise 3D trajectories in the RGS. The RGS tracks the implanted marker on the image, and this chosen marker's position viewed in 3 dimensions. Using X-ray fluoroscopy devices in two distinct planes, the location of marker on the fluoroscopic image is automatically extracted using the pattern recognition technology of the RGS and the spatial position of the marker is calculated and monitored throughout the treatment. Synchronized irradiation of the tumor with gating control occurs only when the marker is within a given tolerance from its planned coordinates relative to the beam isocenter. This synchronized irradiation is performed at high speed which enables accurate irradiation of a tumor whose position may move inside the body, e.g., due to respiration. ## Intended Use / Indications for Use The Real-time Image Gating System is intended for use with compatible Hitachi proton beam therapy systems and is designed to generate gating signals to deliver a proton beam when the position of a fiducial marker, which is implanted near a tumor and tracked by use of X-ray fluoroscopy, is within a given tolerance from its planned position. ### Summary of Technological Characteristics The RGS is a software-based accessory installed in the PBTS workstation and receives information from the PBTS imaging systems, processes the images, and sends timing signals to the PBTS irradiation controller. Similarly, the Verisuite and XVI predicates use software-based image processing systems for verification. This RGS system recognizes the position of a fiducial marker in the human body at a regular frame rate using the fluoroscopic X-ray imaging systems of the PBTS. Similarly, the Verisuite and XVI use fluoroscopic X-ray during treatment to identify implanted fiducial markers. Although neither the XVI nor the Verisuite includes a gating functionality, each can be used with separately-controlled gating system. Although the inclusion of the gating functionality could impact the safety or effectiveness of the device, it does not raise new questions of safety or effectiveness. In addition, other legally-marketed devices with respiratory gating systems have been cleared by the agency to control the delivery of radiation therapy, including Anzai Medical's AZ-733VI respiratory gating system (K160432). The gating of the proton beam is an {5}------------------------------------------------ additional safety feature of the RGS that reduces proton beam exposure to areas outside of the target treatment area ## Performance Data The following tests were performed to establish equivalence of the Real Time Gating System: - . Dose measurement of fluoroscopic X-ray at the isocenter and skin surface position on the X-ray tube side - Recognition accuracy of a static fiducial marker . - System latency - . Tracking of moving marker - Interlock interface testing ● - Interplay effect ● ### Conclusions The Real Time Gating System is as safe and effective as the VeriSuite and XVI devices. The Real Time Gating System has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor differences in indications do not alter the intended use of the device and do not affect its safety and effectiveness when used as labeled. In addition, the minor technological differences between the Real Time Gating System and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the Real Time Gating System is as safe and effective as the predicate devices. Thus, the Real Time Gating System is substantially equivalent.